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Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia (OVANOX)

Primary Purpose

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Imaging with 18F-EF5 PET/CT
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring advanced ovarian cancer, EF5-PET/CT, hypoxia

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • newly diagnosed advanced epithelial ovarian, primary peritoneal or fallopian tube cancer.
  • age 18-79 years
  • informed concent

Exclusion Criteria:

  • previous cancer
  • pregnancy or nursing

Sites / Locations

  • Turku University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PDS

IDS

Arm Description

18F-EF5 PET/CT and 18F-FDG PET/CT scan prior to primary cytoreductive surgery and targeted sample collection during primary cytoreductive surgery

18F-EF5 PET/CT and 18F-FDG PET/CT scans prior to diagnostic laparoscopy and after neoadjuvant chemotherapy before interval cytoreductive surgery . Targeted sample collection during diagnostic laparoscopy and interval cytoreductive surgery

Outcomes

Primary Outcome Measures

18F-EF5 maximum standardized uptake values (SUVmax)
Tumor and musculus gluteus maximus SUVmax ratio ≥1.5 is considered to refer to hypoxia

Secondary Outcome Measures

Correlation between the uptake of 18F-EF5 isotope in PET/CT and immunohistochemical profile of tumor tissue
Disease-free survival
Overall survival

Full Information

First Posted
January 11, 2019
Last Updated
August 5, 2019
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04001023
Brief Title
Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia
Acronym
OVANOX
Official Title
Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this non-randomized prospective study is to use 18F-EF5-PET/CT imaging to identify and locate intraabdominal hypoxic ovarian cancer lesions. With targeted surgical sampling, precisely obtain hypoxic and potentially chemoresistant cancer tissue for our analyses and identify key molecular differences between hypoxic and non-hypoxic tumors within the same patient. A portion of advanced stage EOC are inoperable at diagnosis and can be treated with neoadjuvant chemotherapy (NACT) before surgery. This approach offers a unique opportunity to study how hypoxic tumor areas respond to treatment.
Detailed Description
MORE SPECIFIC AIMS To validate the feasibility of PET-tracer EF5 in EOC imaging. Quantify the amount and exact locations of hypoxic tumors in EOC patients using herein developed protocol and tracers (18F-EF5 and 18F-FDG) in diagnostic and neoadjuvant settings. Measure the non-cancer related EF5 accumulation spots and establish the potential pitfalls in abdominal EF5 imaging Establish a method to verify hypoxic locations with 18F-EF5-PET/CT information during the operation. Develop and validate a model that predicts chemotherapy response based on functional imaging information. To reveal hypoxia related alterations in collected tissue samples (i.e. altered DNA damage repair, altered mitochondrial respiratory functioning, overexpression of hypoxia response elements etc)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma, Hypoxia
Keywords
advanced ovarian cancer, EF5-PET/CT, hypoxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PDS
Arm Type
Experimental
Arm Description
18F-EF5 PET/CT and 18F-FDG PET/CT scan prior to primary cytoreductive surgery and targeted sample collection during primary cytoreductive surgery
Arm Title
IDS
Arm Type
Experimental
Arm Description
18F-EF5 PET/CT and 18F-FDG PET/CT scans prior to diagnostic laparoscopy and after neoadjuvant chemotherapy before interval cytoreductive surgery . Targeted sample collection during diagnostic laparoscopy and interval cytoreductive surgery
Intervention Type
Device
Intervention Name(s)
Imaging with 18F-EF5 PET/CT
Other Intervention Name(s)
Collection of targeted samples during surgery
Intervention Description
Both 18F-FDG PET/CT and 18F-EF5 PET/CT imaging are performed in 1) preoperative work-up to clarify the disease distribution, 2) before IDS to evaluate treatment response to NACT (IDS arm); targeted samples from hypoxic and non-hypoxic tumors are collected during surgery
Primary Outcome Measure Information:
Title
18F-EF5 maximum standardized uptake values (SUVmax)
Description
Tumor and musculus gluteus maximus SUVmax ratio ≥1.5 is considered to refer to hypoxia
Time Frame
2-3 years
Secondary Outcome Measure Information:
Title
Correlation between the uptake of 18F-EF5 isotope in PET/CT and immunohistochemical profile of tumor tissue
Time Frame
2-3 years
Title
Disease-free survival
Time Frame
5 years
Title
Overall survival
Time Frame
5 years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: newly diagnosed advanced epithelial ovarian, primary peritoneal or fallopian tube cancer. age 18-79 years informed concent Exclusion Criteria: previous cancer pregnancy or nursing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maren Laasik, MD
Phone
+35823130000
Email
maren.laasik@utu.fi
Facility Information:
Facility Name
Turku University hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sakari Hietanen, MD, PhD, Adj. prof
Phone
+35823130000
Email
sakari.hietanen@tyks.fi
First Name & Middle Initial & Last Name & Degree
Johanna Hynninen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marko Seppänen, MD, PhD, Adj. prof.
First Name & Middle Initial & Last Name & Degree
Maren Laasik, MD
First Name & Middle Initial & Last Name & Degree
Sakari Hietanen, MD, PhD, Adj. pr

12. IPD Sharing Statement

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Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia

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